Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the pharmacokinetics and safety between single administration of "br6002" and coadministration of "br6002a" and "br6002b" under fed conditions in healthy adult volunteers

Conditions: Gastric or Duodenal Ulcer

Summary: the purpose of this clinical trial is evaluate the pharmacokinetics and safety between single administration of "br6002" and coadministration of "br6002a" and "br6002b" under fed conditions in healthy adult volunteers


Eligibility criteria:
inclusion criteria: * those who weigh 55 kg or more for men and 50 kg or more for women and have body mass index (bmi) within the range of 18.0 to 30.0 kg/m2 at screening. * those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using methods of contraception (in the case of a female subject, hormone drugs is excluded) accepted in clinical trial from the date of the first administration of the investigational products to 7 days after the last administration and disagrees to provide their sperm or ovum. * methods of contraception accepted in clinical trial: combined use of intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used * those who sign written consent spontaneously after listening to and understanding sufficient explanation of the purpose and contents of this clinical trial, characteristics of the investigational products, expected adverse events, etc. exclusion criteria: * those who have clinically significant diseases or past history of the gastrointestinal system, cardiovascular system, endocrine system, respiratory system, hemato-oncologic disease, infectious disease, kidney \& genitourinary system, neuropsychiatric system, musculoskeletal system, immune system, ent system, skin system, ophthalmic system. * those who have a medical history of gastrointestinal surgery (except for simple appendectomy, hernia surgery) or gastrointestinal diseases that may affect the absorption of drugs. * those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 1month prior to the first day of administration or have taken etc, otc, herbal medicine and health functional foods concerned about affecting this clinical trial within 10 days prior to the first day of administration. (however, participation is possible considering pharmacokinetics and pharmacodynamics such as interaction of investigational products, half-life of concomitant drugs) * those who have participated in other clinical trials or bioequivalence tests and administered their investigational products within 6 months prior to the first administration date. * those who are unable to consume high-fat meals provided during this clinical trial. * in the case of a female subject, those suspected pregnancy, pregnant woman, lactating woman.
plasma ctdna in patients undergoing diagnostic colonoscopy

Conditions: Colon Cancer; Colon Adenomas; Colon Polyps

Summary: when the dna inside of human cells undergoes certain alterations (mutations), the cells may develop into a cancer. the cancer cells may shed this dna into the blood stream. this circulating tumor dna (ctdna) can be detected by very sensitive, specialized laboratory tests. measurement of ctdna has been shown to be useful for following patients with known cancer. it has also been found in the circulation of some patients with early stage cancer. the purpose of this study is to examine blood specimens for the presence of ctdna in individuals without known cancer who are scheduled to undergo a screening or diagnostic colonoscopy in order to see if the ctdna test can detect a cancer or precancerous condition at a very early stage before the patient becomes symptomatic. the results of this study should help define the role of ctdna in the detection of early stage colon cancer and to define how sensitive it is (i.e. how well it picks up cancer when it is present) and how specific it is (i.e. how often is ctdna found in patients with benign diseases or no abnormalities).

after the participants have undergone the informed consent process, they will have 30 milliliters (approximately two tablespoons) of blood drawn. this will be done prior to their scheduled screening or diagnostic colonoscopy. if the patient has indicated a desire to receive the results of their test, they will receive a written description, as will their primary care physician. the patients will be contacted yearly for up to 5 years by the study staff to learn whether they have been found to have a diagnosis of colon or other cancer.

Eligibility criteria:
inclusion criteria: . * 18 years of age or older who are scheduled to undergo a screening or diagnostic colonoscopy by dr. phillip fleshner exclusion criteria: * prior history of cancer excluding basal cell carcinoma of the skin

Keywords: colon cancer colon polyps colon adenomas colonoscopy circulating tumor dna
virtual teach-to-goal education vs. brief education for children

Conditions: Asthma; Bronchospasm; Shortness of Breath

Summary: the purpose of this study is to evaluate the effectiveness of two different ways to teach hospitalized children how to use a metered dose inhaler and to follow-up after discharge home from the hospital to determine durability of the education.

asthma is the most common chronic childhood condition and has significant adverse consequences. one in 12 united states children has asthma, resulting in 13.4 million missed school days, 1 million emergency department visits, and 140,000 hospitalizations annually. a key barrier to self-management of asthma is improper use of respiratory inhalers, which limits disease control. better inhaler technique is associated with improved asthma outcomes for children. assessment and education of inhaler technique are recommended at all healthcare encounters, however it is limited in practice because it is resource intensive (both personnel and time) and lacks fidelity. thus, low-resource interventions that accurately teach inhaler skills are needed to impact pediatric asthma outcomes. teach-to-goal (ttg) is a patient-centered strategy that uses tailored rounds of teaching and assessments to ensure mastery of inhaler technique. studies show it is effective but resource intensive. a "virtual ttg" (v-ttg) intervention represents an opportunity to deliver inhaler technique education with a high-fidelity, low-resource, and feasible strategy. the module utilizes innovative learning technology with video demonstrations and assessment questions to tailor education to each user; the cycles of assessment and education continues until satisfactory mastery is achieved. this study evaluates the comparative effectiveness of this high-fidelity, low-resource, and feasible model (v-ttg) versus a standardized brief intervention that mimics usual care to deliver tailored inhaler technique education to children with severe asthma via a randomized clinical trial.

Eligibility criteria:
inclusion criteria: 1. the child is between the ages of 5-10 years old 2. the child is admitted for an asthma exacerbation, wheezing, or bronchospasm 3. the child is admitted to the pediatric hospital medicine service at comer children's hospital 4. the child is prescribed albuterol exclusion criteria: 1. the child/parent decline or unable to provide consent/assent, do not speak/read english 2. the child cannot use an inhaler by themselves without a mask 3. the child previously participated in this study 4. the child is currently in the pediatric intensive care unit (picu)

Keywords: inhaler education asthma learning module virtual teach to goal
digital therapeutic for adolescent depressive symptoms in cardiology and gastroenterology

Conditions: Depressive Symptoms; Major Depressive Disorder; Depression; Cardiology; Gastrointestinal Diseases; Depressive Disorder; Depressive Episode; Adolescent Behavior; Adolescent - Emotional Problem

Summary: the primary aim of this pilot study is to assess the feasibility, acceptability, and preliminary evidence of efficacy of a self-guided, cognitive behavioral therapy (cbt)-based mobile app intervention (sparkrx) for symptoms of depression among adolescents being treated in specialty medical care settings at children's hospital of los angeles (chla).

self-report assessments will be collected at pre, post and 1-month follow up time points. weekly phq-8 assessments will also be collected during the 5-week intervention as well as at pre, post and 1- month follow up time points. study aims involve evaluating: * feasibility of recruiting and enrolling adolescents with elevated symptoms of depression from the cardiology and gastroenterology programs at chla. * retention, program adherence, completion, and withdrawal rates. * safety of the intervention, including reported adverse and serious adverse events * perceived utility, usability, and enjoyment of the sparkrx app by adolescents * clinically significant changes in pre- to -post treatment depressive symptoms and persistence of such gains at 1 month follow up.

Eligibility criteria:
inclusion criteria: * 13-22 years of age at time of enrollment * moderate-severe self-reported symptoms of depression at baseline (phq-8 \>=5) * under the care of a us-based healthcare provider and willing and able to provide the name and contact information of the provider during consent * english fluency or proficiency and literacy of adolescent and consenting legal guardian, if required * access to an eligible mobile device (capable of installing the app) and regular internet access * willing to provide informed e-consent/assent and have legal guardian willing to provide informed e consent (if required) exclusion criteria: * change in concurrent treatment (medication, and/or psychotherapy) for depression 30 days prior to study enrollment * suicide attempt within the past year * active suicide ideation with intent * previously participated in user testing or clinical testing of the spark app * any condition, comorbidity, or event that, in the opinion of the investigator, will prevent the participant from adhering to the protocol or benefitting from the treatment (e.g., unable to perform informed assent or consent, treatment resistance as determined by investigator) or will prevent investigators from being able to ensure safety (e.g., will be leaving the country during study time period)

Keywords: depression mental health adolescent depression
transcutaneous posterior nerve stimulation intreatment of fecal incontience

Conditions: Fecal Incontinence

Summary: shafik and colleagues were the first to report the use of posterior tibial nerve stimulation (ptns) for fi, and they documented improved continence after 4 weeks course. subsequent studies documented percutaneous and transcutaneous ptns as effective methods for treatment of fi, with a short term reduction in incontinence episode by 50-80 %. percutaneous ptns (pptns) showed a greater effect than transcutaneous ptns (tptns) and this may be assumed due to the presence of the stimulating electrode very close to the posterior tibial nerve. however, tptns is more preferable to percutaneous ptns because of the concern about the insertion of a needle may result in stimulation that is sufficient to produce a neuromodulatory effect.

treatment of fnrfi is often difficult and requires prolonged therapies with unexpected responses and frequent relapses. the corner-stones in treatment of fnrfi are education, positive motivation, and toilet training. preparation of children and their parents for a long-lasting treatment is mandatory with the expectation of many ups and downs. the main goal is to have regular bowel movements and normal continence and this can be achieved by teaching the child the importance of regular toilet use and avoid urges. many previous studies, reported the short term effect of tptns in treatment of fnrfi. however, there are sufficient studies evaluating the long term effect of tpns and this has motivated the authors to conduct of this study the aim of this study is to evaluate the long term outcome and quality of life in children with functional non-retentive fecal incontinence and received bilateral transcutaneous posterior tibial nerve stimulation therapy.

Eligibility criteria:
inclusion criteria: * age ranged from (6-14 years) with fnrfi with normal bowel habits * children with normal defecation frequency and normal stool consistency * children with incontinence score ranging from 8-22 according to vaizey score exclusion criteria: * children who have traumatic sphincter injury. * children who have fecal impaction * children who have spinal diseases causing incontinence * children who have anorectal malformation * children who were not cooperative

Keywords: posterior tibial nerve stimulation fecal incontinence long term effect
physiotherapy techniques in adult neck pain

Conditions: Neckache

Summary: to compare the effectiveness of thoracic manipulation and met on chronic mechanical neckache

it is a randomized control clinical trail to compare the effectiveness of physical exercises for the management of chronical mechanical neckache .so we employed thoracic manipulation for experimental group and met (muscle energy technique) for control group

Eligibility criteria:
inclusion criteria: * male and female patients with mechanical neck pain having age group of 18 to 60 years. * mechanical neck pain having activities of daily living * mechanical neck pain affecting sleep exclusion criteria: patients with following conditions will be excluded * osteoporosis * radiculopathy * pregnancy * systemic inflammatory condition * neurological deficit * arthritic conditions * head injuries

Keywords: neckache
the effects of blood pressure reduction on cerebral perfusion and cognition in the elderly population

Conditions: Hypertension

Summary: the purpose of this study is to determine if a reduction in systolic blood pressure induced by anti-hypertensive medication results in changes in cerebral perfusion and cognition in hypertensive elderly. hypertensive elderly will be treated using open-label anti-hypertensive medication for 8-12 weeks. changes in cerebral perfusion and cognition will be assessed before and after treatment.


Eligibility criteria:
inclusion criteria: * age \>= 70 years * systolic office blood pressure \>= 160 mmhg * systolic home blood pressure \>= 155 mmhg exclusion criteria: * diabetes mellitus * atrial fibrillation * dementia * renal failure requiring dialysis * life expectancy of less than 1 year * disabling stroke * contraindication for mri or anti-hypertensive medication * systolic blood pressure \> 220 mmhg

Keywords: blood pressure aging cerebrovascular circulation hypertension
effect of telehealth mindfulness on sleep and anxiety in acquired brain injury population

Conditions: Acquired Brain Injury

Summary: the goal of this study is to learn the effect of a telehealth mindfulness meditation program on sleep quality and anxiety in individuals with brain injury living in the community. the main questions it aims to answer are: * does an eight-session mindfulness meditation program change sleep quality as assessed by the pittsburgh sleep quality index (psqi) in individuals with acquired brain injury? * does an eight-session mindfulness meditation program change anxiety levels as assessed by the patient reported outcomes measurement information system (promis) anxiety short form in individuals with acquired brain injury? participants will: * complete eight sessions of mindfulness meditation over 4 to 5 weeks * complete two mindfulness meditation sessions per week. * complete two additional sessions for pre- and post-test measurements.

this is a pilot study examining the effects of a mindfulness meditation program on sleep quality and anxiety levels in individuals with acquired brain injury living in the community. participants will receive a thirty-minute mindfulness meditation session. each thirty-minute session will consist of five minutes of introduction, 15 minutes of guided mindfulness meditation, and 10 minutes of education and discussion. participants will need to complete eight sessions of mindfulness meditation and pre-and post-tests to be included in the data analysis.

Eligibility criteria:
inclusion criteria: * known diagnosis of acquired brain injury * score 19 or below on the short orientation-memory-concentration test of cognitive impairment (somc) * 18 years or older * can speak and comprehend english * have access to an internet connection and an electronic device exclusion criteria: • diagnosis of aphasia.

Keywords: sleep anxiety mindfulness meditation acquired brain injury
blood flow technique effect on the muscle mechanics

Conditions: Biceps; Muscle Rigidity

Summary: this study will be a study in which we take measurements with the myotonpro device to determine whether the resistant exercises performed without the blood flow restrictive technique and with the blood flow restrictive technique affect the biceps muscle of the participants, who were divided into groups by randomization method after determining the 1 max repetition you can lift.


Eligibility criteria:
inclusion criteria: * being a healthy male or female volunteer between 18 and 35 (who has not participated in any resistance training program for at least 6 months). * being right-hand dominant according to the results of the edinburgh handedness inventory. exclusion criteria: * having a history of biceps musculoskeletal injury. * having any condition that prevents participation in resistance exercise. * having cardiovascular disease. * using medication for blood pressure control.
a safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy study of mbs303 in b-cell nhl

Conditions: Non-Hodgkin's Lymphoma

Summary: this is a phase i/ⅱ, multicenter, open-label, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (pk), pharmacodynamics(pd) and efficacy of a novel t-cell bispecific (tcb), mbs303, administered by intravenous (iv) infusion in participants with relapsed or refractory b-cell nhl. this entry-to-human study consists of 2 parts: a dose escalation part (phase i) and an expansion part (phase ⅱ)


Eligibility criteria:
inclusion criteria: 1. able and willing to provide written informed consent and to comply with the study protocol. 2. adult patients, ≥18 years of age; 3. cd20+ b-cell non-hodgkin lymphoma who have relapsed after or failed to respond to at least one prior treatment regimen with an anti-cd20 monoclonal antibody and for whom there is no available therapy expected to improve survival; 4. eastern cooperative oncology group (ecog) performance status of 0 or 1; 5. life expectancy ≥3 months; 6. measurable disease, defined as at lease one bi-dimensionally measurable nodal lesion, defined as \>1.5 cm in its longest dimension, or at least one bi-dimensionally measureable extranodal lesion, defined as \>1.0 cm in its longest dimension 7. adequate hematologic, hepatic, and renal function. exclusion criteria: 1. chronic lymphoblastic leukemia, burkitt lymphoma or lymphoplasmacytic lymphom; 2. history of central nervous system (cns) lymphoma or other cns disease; 3. participants with known active infection, including bacterial, viral, parasite, mycobacterial, or other infections (excluding nail bed fungal infections); 4. surgery, chemotherapy, targeted therapy, immunotherapy, radiation therapy, tumor embolization, or other antitumor therapy within 28 days prior to the first mbs303; 5. active or suspected autoimmune diseases; 6. known severe allergic reaction or/and infusion reaction to monoclonal antibody; 7. evidence of significant, uncontrolled concomitant disease; 8. major surgery within 28 days prior to the first mbs303 administration or expected to undergo major surgery during the study treatment; 9. history of another invasive malignant tumors in past 3 years; 10. participant with history of confirmed progressive multifocal leukoencephalopathy (pml); 11. severe hemorrhagic diseases such as hemophilia a, hemophilia b, vascular hemophilia, or spontaneous bleeding requiring blood transfusion or other medical intervention; 12. infection with human immunodeficiency virus (hiv), hepatitis b or hepatitis c (including hbsag, hbcab positive with abnormal hbv dna or hcv rna); 13. pregnant or lactating women; females of childbearing potential (fcbp) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study: 1) while participating in the study; 2) for at least 12 months after discontinuation of all study treatments.
feasibility study of barrier enhancement for eczema prevention

Conditions: Eczema

Summary: the purpose of this protocol is to determine the feasibility of doing larger follow-up studies examining whether emollients used from birth can prevent eczema in high-risk babies and to help investigators find out if emollients (moisturizing skin creams) used from birth can prevent eczema in high-risk babies. hypothesis: enhancing the skin barrier from birth using emollients will prevent or delay the onset of eczema, especially in predisposed infants.


Eligibility criteria:
inclusion criteria: 1. participant must have a parent or sibling with a history of at least one of the following: eczema, allergic rhinitis or asthma 2. infant in overall good health 3. mother between the ages of 16 and 45 years of age at delivery; infant from birth thru 6 months of age 4. capable of giving informed consent exclusion criteria: 1. preterm birth defined as birth prior to 37 weeks gestation 2. major congenital anomaly 3. hydrops fetalis 4. significant dermatitis at birth not including seborrheic dermatitis ("cradle cap") 5. any immunodeficiency disorder or severe genetic skin disorder 6. any other serious condition that would make the use of emollients inadvisable 7. any other major medical problems that the investigator deems may increase the risk of adverse events with the intervention
liraglutide as add on therapy on metformin in women with polycystic ovary syndrome

Conditions: PCOS; Obesity

Summary: the purpose of this study was to determine whether combined treatment with liraglutide and metformin is more effective than metformin as monotherapy in the treatment of obese women with polycystic ovary syndrome (pcos). we anticipated greater changes in body weight in patients on combined treatment than in those on monotherapy.


Eligibility criteria:
inclusion criteria: * 18 years old to menopause * polycystic ovary syndrome (nichd criteria) * bmi of 30 kg/m² or higher exclusion criteria: * type 1 or type 2 diabetes mellitus * history of carcinoma * cushing's syndrome or congenital (non-classic) adrenal hyperplasia * personal or family history of men 2 * significant cardiovascular, kidney or hepatic disease * the use of medications known or suspected to affect reproductive or metabolic functions * the use of statins, within 90 days prior to study entry

Keywords: response to therapy